26 January 2010

Ok, we all have ports implanted under our skin.. when we go to get our fills the docs use something called a huber needle, They should be using a non-coring needle on us.. Anyway, the FDA just annouced a recall on some brands of huber needles I have bolded the brands below.. So the next time you go for a fill ask your doc or PA what kind of huber needle they are using and are they aware of the recall.. just passing some industry compliance info on..

FDA Announces Class I Recall of Certain Infusion Set NeedlesHuber needles used in implanted ports to withdraw blood, inject medications, and other solutions

The U.S. Food and Drug Administration today announced a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation.

Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for the withdrawal of blood and infusion of medication, nutritional solutions, blood products, and imaging solutions. These needles should be designed to penetrate the port without cutting and dislodging any silicone cores (or slivers) from the ports into which they are inserted.
Inspections conducted in October 2009 of Nipro facilities in Japan found that their needles “cored” in 60 to 72 percent of tests. The reason for this coring is related to design and manufacturing processes, which the FDA continues to investigate.

There are more than 2 million units impacted by this recall in distribution nationwide. Recalled needles were manufactured from January 2007 to August 2009. Units subject to recall have a lot number that begins with “07,” “08,” “09,” and one of the following product codes or catalog numbers:

4 comments:

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